Evaluation of the results of using 25 μg sublingual misoprostol and Foley catheter together and each one alone in preparing cervix in low-term term pregnancies for termination of pregnancy with less than 4
1) Objectives: The purpose of this study is to evaluate the benefits of sublingual misoprostol and Foley catheter and the simultaneous use of these two to achieve the best cervical preparation for termination of pregnancy.
2) Design: A one-way blind intervention will be conducted.
3) Setting & Conduct: Pregnant women with indication of termination of pregnancy will be randomly divided into 3 groups. The first group will receive only 25 μg sublingua misoprostol, the second group 25 μg sublingual misoprostol and foley catheter (30 mg normal saline) simultaneously, and the third group will receive only foley (30 mg normal saline). The amount of contractions in the uterus will be measured before intervention, 6, 12 and 18 hours after intervention.
4) Inclusion criteria: Pregnant women who indicate a termination of pregnancy (37-42 weeks); have normal delivery conditions: Cephalic presentation; women aged 18-45; urine score less than 4
Exclusion criteria: Abnormal heartbeat; Vaginal bleeding; Placenta praevia & Placental abruption; Multiple birth; Non-Cephalic presentation & Macrosomia; Infertility history greater than or equal to 6 years old and abnormal or fetal death;
Multi-frequency higher than most 7; Rupture of Membeans; Intrauterine growth restriction and weighing over 4000 grams; History of uterine surgeries; tachycardia in mother; Preeclampsia; Abnormal liver and kidney tests.
5) Intrventions: The first group will receive only 25 μg sublingua misoprostol, the second group 25 μg sublingual misoprostol and foley catheter (30 mg normal saline) simultaneously, and the third group will receive only foley (30 mg normal saline).
6) main outcome measures (variables): Termination of pregnancy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072326695N2
Registration date:2017-07-31, 1396/05/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-31, 1396/05/09
Registrant information
Name
leila khayat zonuzi
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 22 2222
Email address
l.zonuzi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of using 25 μg sublingual misoprostol and Foley catheter together and each one alone in preparing cervix in low-term term pregnancies for termination of pregnancy with less than 4
Public title
The effect of sublingual misoprostol and Foley catheter on termination of pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women who indicate a termination of pregnancy (37-42 weeks); have normal delivery conditions: Cephalic presentation; women aged 18-45; urine score less than 4
Exclusion criteria: Abnormal heartbeat; Vaginal bleeding; Placenta praevia & Placental abruption; Multiple birth; Non-Cephalic presentation & Macrosomia; Infertility history greater than or equal to 6 years old and abnormal or fetal death;
Multi-frequency higher than most 7; Rupture of Membeans; Intrauterine growth restriction and weighing over 4000 grams; History of uterine surgeries; tachycardia in mother; Preeclampsia; Abnormal liver and kidney tests
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2489
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80-O84
ICD-10 code description
delivery
Primary outcomes
1
Description
Termination of pregnancy
Timepoint
Before intervention, 6 hours after intervention, 12 hours after intervention, 18 hours after intervention
Method of measurement
The amount of contractions of the womb
Secondary outcomes
empty
Intervention groups
1
Description
Group I: Sublingual misoprostol (25 μg)
Category
Other
2
Description
Group III: Foley catheter with 30 ml normal saline
Category
Other
3
Description
Group II: Sublingual misoprostol 25 μg and foley catheter (30 ml normal saline) simultaneously
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Dr Leila Khayat zonuzi
Street address
Yas Hospital, North Nejatollahi st., Karimkhan Zand st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz blvd. and Qods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yas Hospital
Full name of responsible person
Dr Leila Khayat zonuzi
Position
Gynecologist
Other areas of specialty/work
Street address
Yas Hospital, North Nejatollahi st., Karimkhan Zand st.
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
l.zonuzi@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yas Hospital
Full name of responsible person
Dr Leila Khayat zonuzi
Position
Gynecologist
Other areas of specialty/work
Street address
Yas Hospital, North Nejatollahi st., Karimkhan Zand st.
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
l.zonozi@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yas Hospital
Full name of responsible person
Dr Leila Khayat zonuzi
Position
Gynecologist
Other areas of specialty/work
Street address
Yas Hospital, North Nejatollahi st., Karimkhan Zand st.
City
Tehran
Postal code
Phone
+98 21 8889 7761
Fax
Email
l.zonuzi@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)